UV-VIS 분광기기의 성능검증을 위한 밸리데이션 가이드라인의 제정 및 응용

The Proposed Validation Guidelines and Their Application for Performance Verification of UV-VIS Spectrophotometer

For the increasing demand for the validation of analytical results, one of the important concerns of the analyst is to be assured that the instrumentation is working to qualified conditions. In this study, we have investigated and compared several validation guidelines of the performance verification of UV-VIS spectrophotometer used in pharmacopoeias of major countries and UV-VIS instrument analytical companies, and we proposed the practically useful validation guidelines of UV-VIS spectrophotometer. Based on our proposed validation guidelines of UV-VIS spectrophotometer, several UV-vis spectrophotometers used in drug manufacturing laboratories were validated for their performances.